UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011525
Receipt number R000013482
Scientific Title Identification of urinary biomarkers in diabetic nephropathy by glycan profiling
Date of disclosure of the study information 2013/08/20
Last modified on 2023/03/05 13:12:57

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Basic information

Public title

Identification of urinary biomarkers in diabetic nephropathy by glycan profiling

Acronym

U-CARE study (Urinary biomarker for continuous and rapid progression of diabetic nephropathy)

Scientific Title

Identification of urinary biomarkers in diabetic nephropathy by glycan profiling

Scientific Title:Acronym

U-CARE study (Urinary biomarker for continuous and rapid progression of diabetic nephropathy)

Region

Japan


Condition

Condition

Diabetic nephropathy

Classification by specialty

Medicine in general Cardiology Endocrinology and Metabolism
Nephrology Neurology

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

Identification of urinary biomarkers to predict the progression of diabetic nephropathy by lectin array analyses

Basic objectives2

Others

Basic objectives -Others

To evaluate the predictive values of urinary markers identified by lectin array analyses

Trial characteristics_1

Exploratory

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

Decline of estimated glomerular filtration rate (eGFR)

Key secondary outcomes

Increase in albuminuria.


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit

80 years-old >

Gender

Male and Female

Key inclusion criteria

The patients with type 1 and type diabetes.

Key exclusion criteria

The patients with new onset of malignancies within 5 years. Liver cirrhosis.

Target sample size

800


Research contact person

Name of lead principal investigator

1st name Jun
Middle name
Last name Wada

Organization

Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences

Division name

Department of Medicine and Clinical Science

Zip code

700-8558

Address

2-5-1 Shikata-cho, Kita-ku, Okayama 700-8558, Japan

TEL

086-235-7235

Email

junwada@okayama-u.ac.jp


Public contact

Name of contact person

1st name Koki
Middle name
Last name Mise

Organization

Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences

Division name

Department of Medicine and Clinical Science

Zip code

700-8558

Address

2-5-1 Shikata-cho, Kita-ku, Okayama 700-8558, Japan

TEL

0862357232

Homepage URL


Email

kokims-frz@okayama-u.ac.jp


Sponsor or person

Institute

Department of Nephrology, Rheumatology, Endocrinology and Metabolism, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences

Institute

Department

Personal name



Funding Source

Organization

Health Labor Sciences Research Grant, Japan

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee

Address

2-5-1 Shikata-cho, Kita-ku, Okayama 700-8558, Japan

Tel

086-235-6503

Email

mae6605@adm.okayama-u.ac.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2013 Year 08 Month 20 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled

777

Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

No longer recruiting

Date of protocol fixation

2012 Year 06 Month 26 Day

Date of IRB

2012 Year 06 Month 26 Day

Anticipated trial start date

2012 Year 06 Month 26 Day

Last follow-up date

2028 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

We will perform the lectin array analyses to identify urinary markers to predict the progression of diabetic nephropathy, i.e. decline of eGFR and increase in albuminuria. We plan to measure the levels ofurinary markers by ELISA, such as Haptoglobin, Alpha-2-macroglobulin, Apolipoprotein A-I, Protein AMBP (alpha-1-microglobulin), Hemopexin, Ceruloplasmin, Alpha-1B-glycoprotein, Prostaglandin-H2 D-isomerase, Alpha-1-acid glycoprotein 1 (orosomucoid), Vitamin D-binding protein, N-acetylmuramoyl-L-alanine amidase, Alpha-2-HS-glycoprotein (Fetuin-A), Angiotensinogen, Kininogen-1, Complement C4-A, Plasma protease C1 inhibitor, Complement C3, Antithrombin-III, Prothrombin.


Management information

Registered date

2013 Year 08 Month 20 Day

Last modified on

2023 Year 03 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013482


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name